Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SparkleFresh Fluoride Toothpaste Recalled by Medline Industries Inc Due to Microbial Contamination of Non-Sterile Product

Date: September 17, 2018
Company: Medline Industries Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medline Industries Inc directly.

Affected Products

SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA

Quantity: 994,756 tubes

Why Was This Recalled?

Microbial Contamination of Non-Sterile Product

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medline Industries Inc

Medline Industries Inc has 153 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report